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YY/T 0606.10-2008: Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage
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| YY/T 0606.10-2008 | English | 259 |
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Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage
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YY/T 0606.10-2008
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Basic data | Standard ID | YY/T 0606.10-2008 (YY/T0606.10-2008) | | Description (Translated English) | Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,114 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-06-01 | | Quoted Standard | GB/T 16886.1-2001 | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the repair or regeneration of articular cartilage implanted inside the object evaluation General. The implant in this section may be of natural or synthetic biological material (biocompatible and biodegradable), or a composite material constituted may contain cells, drugs, or growth factors, synthetic peptides, and other bioactive or cDNA plasmids factor. This standard specifies the rabbits, dogs, pigs, goats, sheep and other different species of animal models and corresponding test procedures, as well as morphological, biochemical and biomechanical tissue analysis results of measurement and evaluation methods. | YY/T 0606.10-2008: Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage
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Tissue engineered medical product.Part 10. In vivo assessment of implantable devices intended to repair or regenerate articular cartilage
ICS 11.040.40
C45
People's Republic of China pharmaceutical industry standards
Tissue-engineered medical products - Part 10. Repair or
Regeneration of articular cartilage implanted into the body evaluation guidelines
Posted 2008-04-25
2009-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0606 "tissue-engineered medical products" is divided into.
--- Part 1. General requirements;
--- Part 3. General classification;
--- Part 4. skin product classification;
--- Part 5. Matrix and stent performance and testing;
--- Part 6. Ⅰ collagen;
--- Part 7. chitosan;
--- Part 8. sodium alginate;
--- Part 9. hyaluronic acid;
--- Part 10. implanted in the body to repair or regenerate cartilage evaluation guidelines;
--- Part 12. cell, tissue, organ processing;
--- Part 13. automatic cell counting method.
This section YY/T Part of 100,606.
This part is proposed by the State Food and Drug Administration.
This part of the jurisdiction of the State Food and Drug Administration seized the Medical Device Quality Supervision and Inspection Center.
This in part by the Chinese Pharmaceutical and Biological Products, Zhejiang University drafted.
The main drafters of this section. Chen Liang, Ouyang magnificent, Xi Tingfei, Wang Chunren.
Tissue-engineered medical products - Part 10. Repair or
Regeneration of articular cartilage implanted into the body evaluation guidelines
1 Scope
YY/T 0606 provisions of this part of the repair or regeneration of articular cartilage implanted in the body of General Evaluation. This section of the implant
Biological material may be natural or synthetic (biocompatible and biodegradable), or a composite structure, can comprise cells, drugs, or growth
Factor, synthetic polypeptides, cDNA plasmid or other bioactive factors.
This section describes the rabbits, dogs, pigs, goats, sheep and other animal models of different species of the genus and the corresponding test procedures, as well as morphology, tissue-ingrowth
The results of measurement and evaluation methods were chemical and biomechanical analysis.
2 Normative references
The following documents contain provisions which, through reference YY/T 0606 and become part of the provisions of this section. For dated references,
All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section
Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997)
3 Terms and Definitions
The following terms and definitions apply YY/T 0606 to the present section.
3.1
Natural cartilage has a similar morphology, biochemistry and tissue formation biomechanical properties of articular cartilage samples.
3.2
Damaged cartilage or a substitute by cell proliferation and extracellular matrix synthesis of new healing process.
3.3
Cartilage matrix contains a large number of parallel or interwoven arrangement of collagen fibers, the chemical composition of cartilage collagen type Ⅰ, no fixed
Few shaped matrix, chondrocytes often distributed in rows between the fiber bundle.
3.4
Located on the surface of the articular cartilage, the main component of cartilage matrix proteoglycans and water, the fibers are made of plastic consisting of collagen type Ⅱ
Protofibrils, cartilage chondrocytes located lacuna.
4. Significance and Use
Objective 4.1 section is to provide a variety of animal models for clinical repair or regeneration of articular cartilage tissue engineered medical products
Before evaluation.
4.2 part comprises animal model introduction, operation points, as well as organizations dealing with qualitative and quantitative analysis of tissue samples and the like.
Users should be in accordance with section 4.3 GB/T 16886.1 Biological Evaluation of Medical Devices standards, making this part of the body
Before evaluation, material and cytotoxicity and biocompatibility tests/or instruments.
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